Automatic On-Off Charger for an Implantable Medical Device

ABSTRACT

An external charger for an implantable medical device is disclosed which can automatically detect an implant and generate a charging field. The technique uses circuitry typically present in an external charger, such as control circuitry, a Load Shift Keying (LSK) demodulator, and a coupling detector. An algorithm in the control circuitry periodically issues charging fields of short duration in a standby mode. If the coupling detector detects the presence of a conductive material, the algorithm issues a listening window during which a charging field is generated. If an LSK reply signal is received at the LSK demodulator, the external charger can charge the implant in a normal fashion. If a movement signature is detected at the LSK demodulator indicative of a predetermined user movement of the external charger, a charging field is issued for a set timing period, to at least partially charge the IPG battery to restore LSK communications.

CROSS-REFERENCE TO RELATED APPLICATIONS

This a non-provisional of U.S. Provisional Patent Application Ser. No.61/587,002, filed Jan. 16, 2012, to which priority is claimed.

FIELD OF THE INVENTION

The present invention relates to wireless external chargers for use inimplantable medical device systems.

BACKGROUND

Implantable stimulation devices are devices that generate and deliverelectrical stimuli to body nerves and tissues for the therapy of variousbiological disorders, such as pacemakers to treat cardiac arrhythmia,defibrillators to treat cardiac fibrillation, cochlear stimulators totreat deafness, retinal stimulators to treat blindness, musclestimulators to produce coordinated limb movement, spinal cordstimulators to treat chronic pain, cortical and deep brain stimulatorsto treat motor and psychological disorders, and other neural stimulatorsto treat urinary incontinence, sleep apnea, shoulder subluxation, etc.The description that follows will generally focus on the use of theinvention within a Spinal Cord Stimulation (SCS) system, such as thatdisclosed in U.S. Pat. No. 6,516,227. However, the present invention mayfind applicability in any implantable medical device system.

As shown in FIGS. 1A-1C, a SCS system typically includes an ImplantablePulse Generator (IPG) 10, which includes a biocompatible device case 12formed of a conductive material such as titanium for example. The case12 typically holds the circuitry and battery 14 necessary for the IPG tofunction, although IPGs can also be powered via external RF energy andwithout a battery. The IPG 10 is coupled to electrodes 16 via one ormore electrode leads (two such leads 18 and 20 are shown), such that theelectrodes 16 form an electrode array 22. The electrodes 16 are carriedon a flexible body 24, which also houses the individual signal wires 26coupled to each electrode. In the illustrated embodiment, there areeight electrodes on lead 18, labeled E₁-E₈, and eight electrodes on lead20, labeled E₉-E₁₆, although the number of leads and electrodes isapplication specific and therefore can vary. The leads 18, 20 couple tothe IPG 10 using lead connectors 28, which are fixed in a non-conductiveheader material 30, which can comprise an epoxy for example.

As shown in the cross-section of FIG. 1C, the IPG 100 typically includesan electronic substrate assembly including a printed circuit board (PCB)32, along with various electronic components 34 mounted to the PCB 32,some of which are discussed subsequently. Two coils (more generally,antennas) are generally present in the IPG 100: a telemetry coil 36 usedto transmit/receive data to/from an external controller (not shown); anda charging coil 38 for charging or recharging the IPG's battery 14 usingan external charger 50. In this example, the telemetry coil 36 andcharging coil 38 are within the case 12, as disclosed in U.S. PatentPublication 2011/0112610. (FIG. 1B shows the IPG 10 with the case 12removed to ease the viewing of the two coils 36 and 38). However, thetelemetry coil 36 may also be mounted within the header 30 of the IPG 10(not shown)).

FIG. 2 shows the IPG 10 in communication with external charger 50 justmentioned. The external charger 50 is used to wirelessly convey power tothe IPG 10, which power can be used to recharge the IPG's battery 14.The transfer of power from the external charger 50 is enabled by a coil(antenna) 52. The external charger 50, like the IPG 10, also contains aPCB 54 on which electronic components 56 are placed. Some of theseelectronic components 56 are discussed subsequently. A user interface,which can include a touchable button 60, an LED indicator 62, a display(not shown) and a speaker (not shown), allows a patient or clinician tooperate the external charger 50. A battery 64 provides power for theexternal charger 50, which battery 64 may itself be rechargeable orreplaceable. The external charger 50 can also receive AC power from awall plug. A hand-holdable case 66 sized to fit a user's hand containsall of the components.

Power transmission from the external charger 50 to the IPG 10 occurswirelessly and transcutaneously through a patient's tissue 25 viainductive coupling. FIG. 3 shows details of the circuitry used toimplement such functionality. For power transmission, control circuitry70 in the external charger 50 outputs a charging signal (typically, an80 KHz pulse train) to an amplifier 72 (to “driver circuitry” moregenerally), which generates a constant AC current Icoil of the samefrequency to create an AC magnetic charging field 96. The controlcircuitry 70 can comprise a microcontroller for example. A capacitor(not shown) is used to tune the resonance of the coil 52 to thefrequency of the AC current (e.g., 80 KHz) generated by the amplifier72. The magnetic field 96 induces a current in the charging coil 38within the IPG 10, which current is rectified 82 to DC levels, and usedto recharge the battery 14, perhaps via a charging and batteryprotection circuit 84 as shown. When charging the battery 14 in thismanner, is it typical that the case 66 of the external charger 50touches the patient's tissue 25, although this is not strictlynecessary.

The IPG 10 can communicate data back to the external charger 50 duringcharging using reflected impedance modulation, which is sometimes knownin the art as Load Shift Keying (LSK). Such back telemetry from the IPG10 can provide useful data concerning charging to the external charger50, such as the capacity of the battery 14, or whether charging iscomplete and the external charger 50 can cease.

Control circuitry 80 in the IPG 10 monitors the battery voltage, Vbat,and with the assistance of LSK modulator 86, produces LSK data. Thecontrol circuitry 80 can include a microcontroller for example, and maybe associated with Analog-to-Digital (A/D) conversion circuitry toprocess and interpret the battery voltage. The control circuitry 80assesses the incoming battery voltage to produce appropriate LSK data atappropriate times. Such LSK data is sent as a serial string of bits tothe gate of transistor 88. The LSK data modulates the state oftransistor 88, which in turn modulates the impedance of the coil 38.When LSK data=1, the transistor 88 is on (closed) which shorts the coil38. When LSK data=0, the transistor 88 is off (opened). (Also shown inFIG. 3 are the Frequency Shift Keying (FSK) modulation 92 anddemodulation 90 telemetry circuitry coupled to telemetry coil 36, whichas noted above, are typically used to communicate with an externalcontroller (not shown)).

Such modulation of the charging coil 38 is detectable at the externalcharger 50. Due to the mutual inductance between the coils 52 and 38,any change in the impedance of coil 38 affects the voltage needed atcoil 52, Vcoil, to drive the prescribed charging current, Icoil: if coil38 is shorted (LSK data=1), Vcoil increases to maintain Icoil; if notshorted (LSK data=0), Vcoil decreases. In this sense, the impedancemodulation of coil 38 is “reflected” back to the charging coil 52, andthus data can be said to be “transmitted” from the IPG 10 to theexternal charger 50, even if not transmitted in the traditional sense.

Changes in Vcoil are sensed at LSK demodulation circuitry 74 to recoverthe transmitted LSK data. The serial stream of demodulated bits is thenreceived at control circuitry 70 so that appropriate action can betaken. For example, if the LSK modulation circuitry 86 in the IPG 10transmits an alternating stream of bits (01010101 . . . ), this might beinterpreted by the control circuitry 70 as a stop charging signal, i.e.,a signal indicating that the battery 14 in the IPG 10 is full, andtherefore that charging can cease. In such an instance, the controlcircuitry 70 can suspend the production of the magnetic charging field96 (i.e., setting Icoil to 0), and may notify the user of that fact (bya graphical display, an audible beep, or other indicator).

An issue arising when inductive coupling is used for power transmissionrelates to the coupling between the coils 52 and 38 in external charger50 and the IPG 10. Coupling, generally speaking, comprises the extent towhich power expended at the transmitting coil 52 in the external charger50 is received at the coil 38 in the IPG 10. It is generally desiredthat the coupling between coils 52 and 38 be as high as possible: highercoupling results in faster charging of the IPG battery 14 with the leastexpenditure of power in the external charger 50. Poor coupling isdisfavored, as this will require high power drain (i.e., a high Icoil)in the external charger 50 to adequately charge the IPG battery 14. Theuse of high power depletes the battery 64 (if any) in the externalcharger 50, and more importantly can cause the external charger 50 toheat up, and possibly burn or injure the patient.

Coupling depends on many variables, such as the permeability of thematerials used in the external charger 50 and the IPG 100, as wellmaterials inherent in the environment. Coupling is also affected by therelative positions of the external charger 50 and IPG 10. The controlcircuitry 70 uses a coupling detector 76 to detect the alignment orproximity between the external charger 50 and the IPG 10. Typically, thecoupling detector 76 includes circuitry that can measure the amplitudeof the voltage across the coil 17, which amplitude can be used as anindicator for the degree of proximity and alignment between the externalcharger 50 and the IPG 10. Coupling detectors 76 are known in the art,and are therefore not discussed in detail here. Additional detailsconcerning alignment detection can be found in commonly owned U.S.Provisional Application No. 61/546,850, filed Oct. 13, 2011 entitled“Charger Alignment in an Implantable Medical Device System EmployingReflected Impedance Modulation.”

Generally, the control circuitry 70 in the external charger 50 indicatesmisalignment to a user via an alignment indicator 78. Often, thealignment indicator 76 comprises a speaker (not shown) for issuing anaudible indication such as a “beep” for example when the externalcharger 50 is misaligned with the IPG 100. (Alternately, a “beep” couldindicate an aligned condition). Alignment indicator 78 can also comprisea visual indicator such as a display or a lamp (e.g., LED 62) on theexternal charger 50, or a tactile indicator such as a vibration motorthat causes the external charger 50 to vibrate. (An audible or tactileindication would be preferred if the external charger 50 isn't easilyviewed by the patient during a charging session). Upon hearing, seeing,or feeling (or failing to see, hear, or feel) such an indication, theuser of the external charger 50 can use his or her hand to thenlaterally shift the position of the external charger 50 until betteralignment with the IPG 10 is achieved, and the indicator ceases (orissues).

FIG. 4 shows the user interface of the external charger 50. Aspreviously mentioned, the user can turn on/off the charging field 96 bypressing the switch 60. The inventor recognizes drawbacks to having anon/off switch 60 on the charger 50, which drawbacks include increasedcost of external charger 50, increased size of user interface, reducedreliability of external charger 50, increased weight of external charger50, etc.

Solutions have been proposed to allow an external charger toautomatically detect when an implant is in its vicinity, and to startcharging automatically. For example, in U.S. Patent ApplicationPublication 2009/0112291, an external charger is disclosed thatexchanges telemetry with an implant to determine whether charging shouldbegin. In the '291 Publication, the external charger periodicallytelemeters to the implant requests to begin charging. If the implant isin the vicinity of the external charger, it can receive these requests,and can reply back to the external charger, which can then begingenerating a changing field. During charging, the external charger canperiodically suspend the charging field to allow the implant totelemeter battery status information, which can allow the externalcharger to cease producing a changing field once the battery in theimplant is fully charged.

The inventor finds the means disclosed in the '291 Publication forautomatically determining implant vicinity and automatically beginningcharging to be less than optimal, as it requires the external charger tohave additional hardware, namely a telemetry transmitter and receiver,and an associated antenna, that are not normally present in an externalcharger, and which are separate from the external charger's chargingcoil. Requiring such additional hardware increases the cost andcomplexity of the external charger.

Additionally, the technique disclosed in the '291 Publication would beineffective if the battery in the implant has become so depleted that itis unable to operate. If that occurs, the implant would not have enoughpower to resolve the periodic request signals from the external charger,nor to reply back to the external charger. The external charger wouldthus conclude that the IPG is not present, and would not provide acharging field, even though the implant clearly needs charging in thiscircumstance.

It is therefore desired by the inventor that an external charger be ableto automatically begin and suspend charging in a solution that does notrequire substantial modification to the hardware normally present in anexternal charger, even when the implant battery is depleted, and thisdisclosure provides such solutions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C show different views of an implantable medical device,specifically an Implantable Pulse Generator (IPG).

FIG. 2 shows wireless links between the IPG and an external charger.

FIG. 3 shows circuitry in both the IPG and external charger forproviding power to the IPG.

FIG. 4 shows turning on/off of the external charger by using an on/offswitch.

FIG. 5 shows improved circuitry for an external charger system in whichthe external charger does not have an on/off switch, includingprogrammed on/off algorithms for automatically charging the IPG.

FIG. 6 shows an example of the on/off algorithm for use in the externalcharger.

FIG. 7 shows the standby mode for the external charger, in which shortduration charging field periods are issued.

FIG. 8 shows how the magnitude of the coil voltage in the externalcharger during the periods can be used to infer external chargerproximity to the IPG or other conductive structure.

FIG. 9 shows a charging field during a listening window that issuesafter the external charger senses proximity to the IPG or otherconductive structure.

FIG. 10 shows the IPG issuing a Load Shift Keying (LSK) reply signal inresponse to the charging field received during the listening window.

FIGS. 11A and 11B show how moving the external charger can be used toindicate its proximity to the IPG during the listening window.

DETAILED DESCRIPTION

An improved external charger is disclosed, which external charger doesnot require a switch to turn on or off the charging field to providepower to the IPG. The external charger automatically determines whetherit is proximate to the IPG, and if so can begin charging. Thisdetermination doesn't require additional telemetry circuitry (such asFSK telemetry circuitry) in the external charger, but instead relies oncircuitry generally already present in an external charger, such ascontrol circuitry, a Load Shift Keying (LSK) demodulator, and a couplingdetector. An on/off algorithm in the control circuitry periodicallyissues charging fields of short duration in a power-saving standby mode.If the coupling detector detects the presence of a conductive material,which might be the IPG requiring charging, the on/off algorithm issues alistening window during which a charging field is generated. If an LSKreply signal is received at the LSK demodulator from the IPG during thelistening window, the external charger can continue charging in a normalfashion. Alternatively, if a movement signature is detected at the LSKdemodulator, indicative of user movement of the external chargerrelative to the IPG, a charging field is issued for a set timing period,with the hope of at least partially charging the IPG battery to thepoint where LSK communications are restored. If neither indication isdetected, the external charger enters a standby mode to save power,which mode is exited only if the external charger senses a change in itsposition.

Circuitry for the improved external charger 150 is disclosed in FIG. 5.In contrast with the prior art external charger 50 (FIG. 3), theexternal charger 150 does not include an on/off switch 60 for turningon/off the charging field 96. Instead, the control circuitry 70 isprogrammed with an on/off algorithm 71 that operates to automaticallydetect when an IPG 110 is present, and to generate a charging field 96to charge the IPG 110's battery 14. An on/off algorithm 81 programmed inthe control circuitry 80 of the IPG 110 complements operation of theon/off algorithm 71 in the external charger 150, as explained furtherbelow.

An embodiment of on/off algorithm 71 is shown in flow chart form in FIG.6. As shown, the external charger 150 periodically generates a magneticcharging field 96 in a standby mode (step 200). These periods 250 areshown in FIG. 7 from the perspective of the voltage on coil 52, Vcoil.The charging field periods 250 are of short duration, td, during whichtime Vcoil will oscillate. The short duration charging field periods 250are produced with a period, tp. In one example, td can equalapproximately 1 millisecond, and tp can equal approximately 1 second.Notice that during the standby mode (step 200), the external charger 150is only producing a charging field 0.1% of the time. While generating acharging field 96 during these periods will expend some energy in theexternal charger 150, such expenditure is tolerable: power in theexternal charger 150 is not critical, because it is relatively easy toreplace or charge the battery 64 in the external charger.

Enable signals 73, 75, 77, and 79 (FIG. 5) can be issued by the controlcircuitry 70 to turn off the various circuit blocks (e.g., the amplifier72, the LSK demodulator 74, the coupling detector 76, and the alignmentindicator 78) between the periods 250 that the external charger 150 isproviding a charging field 96. One skilled in the art will understandthat such circuit blocks can be disabled by disconnecting the block fromthe power supply using a switch, although this isn't shown.

During the standby mode, the external charger 150 attempts to sensewhether an IPG requiring charging could be in its vicinity by assessingVcoil, as shown in FIG. 8. Specifically shown is how Vcoil changes asthe external charger 150 is brought closer to the IPG 110 during eachsuccessive periodic generation of the charging field 96. As shown, Vcoildecreases as the external charger 150 approaches the IPG 110. Thisoccurs because of mutual inductance: the coil 52 in the external charger150 is loaded by the conductive elements in the IPG 110, mostsignificantly the IPG's conductive case 12. Specifically, the magneticcharging field 96 will generate eddy currents in the conductive case 12and other conductive structures in the IPG, which eddy currents producean opposing magnetic field, making it easier for the external charger150 to generate the prescribed constant Icoil current through the coil52. As a result, Vcoil drops, which can be sensed at the couplingdetector 76. Eventually, Vcoil will drop below a threshold, Vt, whichthreshold Vt can be programmed 83 (FIG. 5) into the coupling detector76. When this occurs (step 202), the coupling detector 76 can indicateto the on/off algorithm 71 that an IPG 110 may be present, and thus thatfurther steps in the algorithm can commence. One skilled will understandthat although Vcoil varies throughout any given period 250 (e.g. at 80kHz), the maximums within each period can be integrated or averaged todetermine a singular Vcoil for each period. If Vcoil is not less than Vt(step 202), the algorithm 71 returns to the standby mode (step 200) toassess Vcoil of future periods 250 relative to the Vt.

Choosing the correct Vt for use in the coupling detector 76 will likelybe based on experimentation, i.e., that point at which the designers ofthe system determine that a particular IPG 110 is suitably coupled tothe external charger 150 to be able to significantly receive thecharging field 96 the external charger 150 produces. The relevantthreshold Vt will be dependent on the charging current, Icoil, used bythe external charger 150 at any given moment. Again, experimentation canyield the Vt v. Icoil data 83 necessary for the external charger 150.

To prevent inadvertent charging, and needless progression through theon/off algorithm 71, the coupling detector 76 may not issue that thethreshold Vt has been crossed until this threshold has been crossed forseveral periods 250 of the charging field. This is desirable to preventalgorithm 71 progression in case of a “glitch” or some passing transientthat causes Vcoil to be less than Vt for an insignificant time or numberof periods. Thus, for example, the algorithm 71 may progress only ifVcoil<Vt for three consecutive periods.

An issue with this approach for determining the vicinity of the IPG 110to the external charger 150 is that other conductive structures asidefrom the IPG 110 may also cause Vcoil to be less than Vt. For example,if the external charger 150 is sitting on or near a metallic structure,such as a metallic table or chair, the on/off algorithm 71 mightconclude that the IPG 110 is in vicinity when it is not. Subsequentsteps of the on/off algorithm 71 deal with this issue by seekingconfirmation that the IPG 110 is indeed in the vicinity of the externalcharger 150 and able to be charged, as opposed to some other conductivestructure.

Although not strictly necessary, at this point the on/off algorithm 71may alert the user that the external charger 150 believes the IPG 110 tobe in its vicinity (step 204). Issuing such a user alert can bebeneficial for a number of reasons. First, it allows the user to movethe external charger 150 away from an interfering conductive structurethat might be falsely causing the alert, for example, away from themetal table on which it is sitting. As will be discussed further below,alerting the user in this manner to move the external charger 150 canprevent the on/off algorithm 71 from needlessly progressing tosubsequent steps that could result in generation of a significantcharging field, and thus waste energy in the external charger 150.Second, if the IPG 110 is actually in the vicinity of the externalcharger 150 and if charging is desired, the alert can notify the user totake certain steps to allow charging to begin, as discussed furtherbelow. The user alert can take forms similar to the indications issuedby the alignment indicator 78 to notify the user about misalignmentduring a regular charging session, such as lighting an LED 62 on theexternal charger 150, or issuing sounds from a speaker (not shown), etc.

In next steps, the external charger 150 seeks to verify whether the IPG110 is actually in its vicinity (as opposed to some other conductivestructure) by generating a charging field during a listening window 260(step 206), as shown in FIG. 9. The listening window 260 can have aduration t1 of about 20 second for example. During the listening window,the LSK demodulator 74 in the external charger 150 looks for anindication whether the IPG 110 is in its vicinity, and such indicationcan be provided in a number of ways. As shown in FIG. 6, a firstindication can comprise an LSK reply from the IPG 110 (step 208), and asecond indication can comprise a signature indicative of predictablemovement of the external charger by the user (step 214). While both ofthese indications are not strictly necessary, they are desired in theon/off algorithm 71 in light of the possibility that the battery 14 inthe IPG 110 may be so depleted that the IPG 110 is essentiallynon-functional, as discussed further below.

The first of these indications—LSK reply—is shown in FIG. 10. During thelistening window 260, the IPG 110 receives the charging field 96 via thecoil 38, rectifier 82, and charging/protection circuitry 84, the latterof which can notify the on/off algorithm 81 in the IPG's controlcircuitry 80 of such receipt. In response, the on/off algorithm 81 canissue an LSK reply signal, which can be demodulated 74 at the externalcharger 150 to inform the external charger that the IPG 110 is truly inits vicinity (step 208) and that a normal charging session can commence(step 212). The LSK reply signal can take many forms, but should bedistinct from other LSK signals, such as stop charging signal 01010101 .. . discussed in the Background. In the illustrated example, the replysignal comprises 110110110110, i.e., three repeating unit of ‘110.’ Thisis desired to give the LSK reply signal a different periodicity than thestop charging signal, thus allowing the LSK demodulator 74 in theexternal charger 150 to more easily differentiate between the two. Otherdifferentiable LSK reply signals could be used, and the illustratedsignal should be understood as merely one example.

Note that the on/off algorithm 81 in the IPG 110 can be programmed toissue the LSK reply signal whenever the IPG 110 first acknowledgesreceipt of a charging field 96. The external charger 150 can provide agap 255 between its last period 250 and the start of the listeningwindow 260, as shown in FIG. 9. The charging field 96 will cease duringthis gap 255, thus ensuring that the IPG 110 will see a new issuance ofa charging field during the listening window 260, and can issue the LSKreply signal at that time. Alternatively, the on/off algorithm 81 in theIPG 110 can ignore charging fields of short duration, such as during theperiods 250, so that LSK reply signals will not needlessly issue duringsuch periods.

The effect of LSK reply signal on Vcoil during the listening window 260is shown in FIG. 10, with ‘1 ’ bits causing an increase (ΔV) in Vcoil.The on/off algorithm 81 in the IPG can issue each of the LSK bits for 1millisecond for example, and thus the entire 12-bit string of the LSKreply signal only takes 12 milliseconds to issue. The LSK demodulator 74is assisted in its demodulation task by knowing the duration of the bitsin the LSK reply signal, as this will make relevant variations in Vcoileasier to identify. The LSK reply signal can issue from the IPG 110repeatedly, for example every second, thus allowing 20 such signals toissue during the 20-second listening window 260, and increasing thelikelihood that the external charger 150 will adequately receive thesignal at least once. Once the demodulator 74 determines whether a LSKreply signal has been received during the listening window 260, itnotifies the on/off algorithm 71 in the external charger 150 of thisfact, so that next steps can be taken. To guard against inadvertentdetection of the IPG, the demodulator 74 may only indicate receipt ofthe reply signal to the on/off algorithm 71 if a number of LSK replysignal are received in a row (for example, three), meaning that thedemodulator 74 in this example would need three seconds to make thisdetermination. Once the demodulator 74 indicates receipt of a replysignal, the on/off algorithm 71 can end the listening window (step 206),and next steps can be taken.

Upon receipt of the LSK reply signal, the on/off algorithm 71 can becertain that the IPG is in its vicinity, and the user alert issuedearlier (if any; step 204) can be extinguished (step 210). Thereafter,on/off algorithm 71 can continue issuing a charging field 96 to chargethe IPG 110 during a normal charging session (step 212), such as isdiscussed in the Background. Note that continuing the charging field 96between steps 206 and 212 without a gap will keep the on/off algorithm81 in the IPG from issuing a new LSK reply signal. However, this is notstrictly necessary, and instead the charging field can cease prior tostep 212. Even if the charging field is continuous between steps 206 and212, the charging fields generated during these steps can be describedas separate charging fields.

During this normal charging session (step 212), the coupling circuitry76 and alignment indicator 78 can operate as normal to inform the userwhether to adjust positioning of the external charger 150 relative tothe IPG 110, and the on/off algorithm 81 can issue the stop chargingsignal (01010101 . . . ) to inform the on/off algorithm 71 in the IPG110 when charging can cease. Other events can occur during the normalcharging session of step 212 as well, such as adjustment of theintensity of the charging field 96 (i.e., adjustment of Icoil), oradjustment of the duty cycle of the charging field (which may benecessary to control heating). See U.S. Patent Application Publication2011/0087307, discussing such details at length. Once charging hasceased, and ignoring counter X for the moment (step 230), the externalcharger 150 can revert back to standby mode (step 200) in preparationfor locating and charging the IPG at some future time.

It may be possible that the IPG 110, even if in the vicinity of theexternal charger 150, is so depleted that it is not able to operate itsLSK circuitry to communicate a LSK reply signal back to the externalcharger 150 during the listening window 260. In this circumstance, thedemodulator 74 can assess whether a second indication is presentindicating the vicinity of the IPG 110, as shown in FIGS. 11A and 11B.

This second indication relies on user manipulation of the externalcharger 150 relative to the IPG 110 during the listening window 260. Asshown in FIG. 11A, the user moves the external charger 150 between aposition A close to the IPG 110 and a position B away from the IPG 110.Position A might comprise the placing the external charger 150 on thepatient's tissue 25 proximate the IPG 110, while position B mightcomprise moving the external charger 150 an arm's length away from theIPG 110.

Providing this type of indication to the external charger 150 requiresprevious training of the user, either by the user's clinician, usermanuals accompanying the system, or other means. For example, a userdesiring to charge of his IPG 110 can be instructed with the followingmovement procedure: place the external charger in position A (againsthis IPG 110) for five seconds, then move it to position B (away) for twoseconds, then back to position A for two seconds, then back to positionB for two seconds, etc. The user can be instructed to continue thiscyclic movement pattern for about 20 seconds, i.e., the duration t1 ofthe listening window 260.

If user alerts are used (step 204), such alerts can inform the user howfar he has to engage in this movement procedure. For example, when theuser places the external charger 150 in position A for five seconds,Vcoil would be less than Vt (step 202), and an alert would issue (step204). The listening window 260 would be started during which a chargingfield is generated (step 206). If the battery 14 in the IPG 110 issufficiently charged to detect the charging field and provide LSKcommunications, the external charger 150 should receive a LSK replysignal in the first five seconds, as described above. This wouldextinguish the alert (step 210), and begin the charging session (step212). Seeing that the alert has been extinguished (step 210), the userwould know that he didn't need to continue the movement procedure, andthat he could simply leave the external charger in position A. If thealert is not extinguished (step 210), the user would know that the IPGbattery 14 is significantly depleted, and to continue the movementprocedure by moving the external charger 150 to position A, then back toB, etc. for the duration of the listening window 260, or at least untilthe movement signature has been received (step 214) and the alert islater extinguished (at step 216), as discussed further below.

If user alerts do not comprise part of the on/off algorithm 71, the usercan simply be instructed to engage in the full movement procedure. Inthis scenario, it is possible that an LSK reply signal will have beensent once the external charger 150 is placed initially in position A,but the user would not know this, and so would engage in the fullmovement procedure to cover the possibility that the IPG was so depletedas to be inoperative. Although the full movement procedure might not benecessary, it would be harmless: if an LSK reply signal had beenreceived, and charging had already begun (step 212) unbeknownst to theuser, moving the external charger away from the implant (position B)would simply mean the implant is not receiving a charge during theserelatively short periods. Indeed, the coupling circuitry 76 andalignment indicator 78 may be useful to notify the user of this fact,i.e., that a charging session had begun (step 212), and that continuingfurther with the movement procedure is unnecessary.

Indication that the movement procedure has been performed during thelistening window 260, and thus that the IPG 110 must truly be present(as opposed to some other conductive structure), occurs when thedemodulator 74 detects the movement signature illustrated in FIG. 11B.As shown, the coil voltage, Vcoil, is smaller when the external charger150 is in position A close to the IPG 110, and is larger when inposition B away from the IPG. This change in Vcoil (ΔV) results from thedifference in mutual inductance that the external charger 150 seesrelative to the IPG 110 in the two positions, as should be clear fromearlier discussion. The demodulator 74 can detect this movementsignature, knowing in advance how long the user has been instructed tohold the external charger in positions A (tA) and B (tB). (tA and tB canbe different, although this example assume they are both about 2seconds). One skilled will understand that the demodulator 74 may needto integrate or average Vcoil to determine whether it is changing with aperiodicity matching the movement procedure, which determination can bemade even in advance of the end of the listening window 260. Note thatthe periodicity generated in Vcoil due to changes in position (FIG. 11B)occurs on a much greater time scale (seconds versus millisecond) thanchanges resulting from LSK telemetry (FIG. 10). As such, the demodulator74 can determine without confusion whether LSK telemetry is present(step 208), or if the movement procedure is occurring (step 214), andthus can inform either indication to the on/off algorithm 71.

Once the demodulator 74 has determined that the IPG 110 is present basedupon the movement signature of FIG. 11B, and has notified the on/offalgorithm 71 of this fact (step 214), the on/off algorithm 71 canconclude that the IPG is present, but must be significantly depleted. Atthis point, user alerts can be extinguished (if any; step 216), and theexternal charger 150 can continue generating a charging field 96 for aset period (step 218). Note that continuing the charging field 96between steps 206 and 218 without a gap will keep the on/off algorithm81 in the IPG from issuing a new LSK reply signal. However, this is notstrictly necessary, and instead the charging field can cease prior tostep 218. Even if the charging field is continuous between steps 206 and218, the charging fields generated during these steps can be describedas separate charging fields. This set period in step 218 is preferablylong enough to sufficiently charge the IPG's battery 14 to allow the IPG110 to once again engage in LSK communications, even if not fullycharged. This set time period may vary between applications, dependingfor example on the depth of the IPG 110 in the patient's tissue 25.However, in one example, the set time period for charging in step 218can comprise 15 minutes.

Ignoring counter X for a moment (step 230), once charging for the settime period has finished (step 218), the on/off algorithm 71 returns tothe standby mode (step 200). Charging of the IPG's battery 14 mayhowever not be complete, and so the algorithm 71 essentially repeats: ifVcoil is low, suggesting external charger vicinity to the IPG (step202), a charging field is issued during a new listening window (step206). If the IPG has been sufficiently charged to allow for LSKcommunications and an LSK reply signal is received (step 208), chargingcan occur as normal until the battery 14 is fully charged (step 212). Ifthe battery 14 is still depleted and LSK communications are still notfunctional, the user can be prompted to engage in the movement procedureagain (step 214) to charge the IPG 110 for another set time period (step218), etc.

As noted earlier, other conductive structures in the vicinity of theexternal charger 150 (aside from the IPG 110) may also signify coupling,and cause Vcoil to be less than Vt (step 202). In this scenario, theexternal charger 150 would not receive an LSK reply signal (step 208),nor would it be likely to receive a movement signature (step 214). Insuch a case, it is not desirable for the external charger 150 togenerate significant charging fields 96 merely because the externalcharger might be proximate to the IPG 110. To handle this scenario, acounter X in employed in the on/off algorithm 71. Essentially, counter Xcounts how many times this scenario occurs, and if a maximum isexceeded, then the on/off algorithm 71 reverts to a standby mode inwhich the absolute value of Vcoil is ignored. This keeps the externalcharger 150 from needlessly issuing listening windows 260 (step 206),and wasting power during such windows by generating a charging field,merely because significant coupling is indicated.

As shown in FIG. 6, if neither an LSK reply (step 208) nor a movementsignature (step 214) are detected by the demodulator 74 at the end ofthe listening window 260, user alerts are extinguished (if present; step220), and the current value of the counter X is compared to a maximum.In the depicted example, this maximum is three, although this couldvary. Assume currently that X=0. Because X is less than three (step222), the counter X is incremented to 1 (step 228), and the standby modeis entered (step 200). If the external charger 150 is still proximate aconductive object (Vcoil<Vt; step 202), the algorithm 71 will repeat,and once again determine that neither an LSK reply nor a movementsignature have been detected. X will thus be incremented to 2 (step228), and the process will again repeat, until X=3 (step 222). At thispoint, the external charger 150 has tried three times to receive areliable indication that the IPG is in its vicinity.

Having determined that this has not occurred, the external charger 150will infer that it must be proximate some conductive structure otherthan the IPG 110. For example, it may be sitting on top of a metaltable. In this case, the on/off algorithm 71 enters a second standbystate (step 224), which similarly to the first standby state (step 200),will periodically (e.g., for 1 millisecond every second) generate acharging field 96. However, further comparisons of Vcoil to Vt duringthe periods are ignored (see, e.g., step 204), and instead the algorithm71 simply assesses whether Vcoil significantly changes in magnitude(step 226). If Vcoil has not significantly changed, for example becausethe external charger 150 is still just sitting on the metal table, thealgorithm 71 stays in the standby mode (step 224) and continues toassess Vcoil (step 226). If Vcoil has significantly changed, thealgorithm 71 infers that the external charger 150's position haschanged; perhaps the user has moved the external charger 150 away fromthe metal table, possibly because he was notified by alerts issuedearlier (if any; step 204). Experience can teach what comprises asignificant change in Vcoil. In one example, a change of 5% in themagnitude of Vcoil can indicate a significant positional change of theexternal charger in step 226.

Given the significance of this positional change, the counter X is setto 0 (step 230), and the first standby mode (step 200) is once againentered. If no conductive structures (including the IPG) are present,Vcoil will be greater than Vt, and the algorithm 71 will merely remainin the standby mode (step 200). If some conductive structure is detected(Vcoil<Vt; step 202), the algorithm 71 will continue as outlined above:if either an LSK reply (step 208) or a movement signature (step 214) isdetected, some charging (either steps 212 or 218) will take place. Notethat after charging has occurred (steps 212 or 218), the counter X isreset to 0 (step 230), because there is no concern at this time that theexternal charger 150 is not actually proximate to the IPG 110. Ifneither an LSK reply or a movement signatures is detected, meaning theexternal charger is still proximate some conductive structure other thanthe IPG 110, the counter X is incremented (step 228), and if theexternal charger 150 is not moved, the on/off algorithm 71 will onceagain enter the second standby mode (step 224) until the situationclears.

One skilled in the art will recognize that modifications to thedisclosed technique are possible, and that the illustrated embodimentsare merely examples. For example, while the LSK demodulator 74 andcoupling detector 76 have been shown for convenience as separate circuitblocks, they could be integrated together into a single circuit blockwhich assesses Vcoil for all purposes, including coupling (step 202), orwhether an LSK reply or movement signature have been received (steps208, 214). Moreover, these blocks 74 and 76 can issue data to thecontrol circuitry 70, and the on/off algorithm 71, in different ways.For example, they can issue the coil voltage, Vcoil, leaving it to theon/off algorithm 71 to make the determinations required for thedisclosed technique. Alternatively, the logic necessary to make thesedeterminations can be present in the circuit blocks 74 and 76, in whichcase these blocks need merely indicate the results of thosedetermination to the on/off algorithm 71 for action. Moreover, thecircuit blocks 74 and 76 can be incorporated into the control circuitry70 itself. In such an embodiment, Vcoil may only need to be digitized ata suitable rate (e.g., with an A/D converter) and sent to the controlcircuitry 70, which in turn would be programmed to perform the functionsof the LSK demodulator 74 and the coupling detector 76, and makenecessary determinations. The functionality of LSK demodulator 74 andcoupling detector 76 can generally be considered as “detectioncircuitry.”

While much of the disclosed technique centered around assessment ofVcoil, this is not strictly necessary. Assessment of Vcoil is sensibleif a constant AC charging current, Icoil, is issued by the amplifier 72.However, the amplifier 72 may also issue a constant AC voltage signal,Vcoil, to generate the charging fields 96, in which case Icoil would bethe interesting parameters to assess, in particular how Icoil changes inlight of changes in mutual inductance provided by the existenceconductive structures, LSK telemetry, etc. In short, any usefulparameter of the charging coil 52 can be used as the basis for makingthe determinations in the disclosed technique.

Moreover, while preferred that the on/off algorithm 71 listens both foran LSK reply signal and a movement signature to cover the possibilitythat LSK communications might not be functional, the algorithm can beimplemented by listening for only one of these two indications. It isalso not strictly necessary that the on/off algorithm 71 use a counteror other measures to prevent inadvertent charging (steps 200 et seq.) inthe event that an implant is not proximate to the charger, although thisis desirable for power savings.

Although particular embodiments of the present invention have been shownand described, it should be understood that the above discussion is notintended to limit the present invention to these embodiments. It will beobvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present invention. Thus, the present invention is intended to coveralternatives, modifications, and equivalents that may fall within thespirit and scope of the present invention as defined by the claims.

What is claimed is:
 1. A method for charging a battery in an implantablemedical device using an external charger, comprising: (a) automaticallydetermining at the external charger that the implantable medical deviceis possibly proximate the external charger; (b) upon determining thatthe external charger is possibly proximate the implantable medicaldevice, automatically generating a second magnetic field from a firstcoil in the external charger; (c) receiving at the external charger andduring the second magnetic field at least one indication from theimplantable medical device; and (d) upon receiving the at least oneindication, automatically generating a third magnetic field from thefirst coil in the external charger to wirelessly charge the battery inthe implantable medical device.
 2. The method of claim 1, wherein step(a) comprises: periodically generating a first magnetic field from thefirst coil in the external charger; and automatically determining duringone or more of the first magnetic fields that the implantable medicaldevice is possibly proximate the external charger.
 3. The method ofclaim 2, wherein determining that the implantable medical device ispossibly proximate the external charger comprises determining aparameter of the first coil during one or more of the first magneticfields.
 4. The method of claim 3, wherein the parameter comprises amagnitude of a voltage or current of the first coil.
 5. The method ofclaim 3, wherein it is determined that the implantable medical device ispossibly proximate the external charger upon the parameter crossing athreshold.
 6. The method of claim 1, wherein the second magnetic fieldis generated for a set time period.
 7. The method of claim 1, whereinthe indication comprises a variation in a parameter of the first coilvoltage.
 8. The method of claim 7, wherein the variation in theparameter of the first coil voltage results from transmitting a replysignal from the implantable medical device.
 9. The method of claim 8,wherein the reply signal is periodically transmitted from theimplantable medical device during the second charging field.
 10. Themethod of claim 8, wherein the implantable medical device has a secondcoil for receiving the second magnetic field, and wherein the replysignal is transmitted by modulating an impedance of the second coil. 11.The method of claim 10, wherein the second coil receives at least thethird magnetic field to wirelessly charge the battery in the implantablemedical device.
 12. The method of claim 7, wherein the variation in theparameter of the first coil voltage results from moving the externalcharger relative to the implantable medical device.
 13. The method ofclaim 12, wherein the external charger is cyclically moved to and fromimplantable medical device.
 14. The method of claim 1, wherein theexternal charger can receive first and second indications during thesecond magnetic field.
 15. The method of claim 14, wherein the firstindication indicate that the IPG's battery is not depleted, and whereinthe second indication indicates that the IPG's battery is depleted. 16.The method of 15, wherein if the first indication is received, the thirdmagnetic field continues until the battery in the implantable medicaldevice has been fully charged, and wherein if the second indication isreceived, the third magnetic field continues for a set time period. 17.The method of claim 1, further comprising: (e) returning to step (a).18. An external charger for charging a battery in an implantable medicaldevice, comprising: a coil; driver circuitry configured to energize thecoil to generate a magnetic field; detection circuitry configured tomeasure a parameter of the coil while it is energized; control circuitrycoupled to the driver circuitry and the detection circuitry; and analgorithm associated with the control circuitry, wherein the algorithmis configured to assess the measured parameter: to determine if theimplantable medical device is possibly proximate to the externalcharger, and if so, to determine if at least one indication from theimplantable medical device has been received, and if so to, energize thecoil to generate a magnetic field to charge the battery in the implant.19. The external charger of claim 18, wherein the algorithm determinesif the implantable medical device is possibly proximate to the externalcharger by periodically generating a magnetic field from the coil in theexternal charger.
 20. The external charger of claim 18, wherein thealgorithm determines if the implantable medical device is possiblyproximate to the external charger by assessing a magnitude of aparameter of the coil while it is energized.
 21. The external charger ofclaim 20, wherein the parameter comprises a magnitude of voltage orcurrent of the coil while it is energized.
 22. The external charger ofclaim 18, wherein the algorithm determines if the implantable medicaldevice is possibly proximate to the external charger by comparing themeasured parameter of the coil to a threshold.
 23. The external chargerof claim 18, wherein the algorithm determines whether the at least oneindication from the implantable medical device has been received byassessing a variation in the measured parameter.
 24. The externalcharger of claim 23, wherein the variation in the measured parametercomprises a serial stream of bits.
 25. The external charger of claim 23,wherein the variation in the parameter indicates that the externalcharger has been moved relative to the implantable medical device. 26.The external charger of claim 23, wherein the variation in the parameteris cyclic.
 27. The external charger of claim 18, wherein the algorithmis configured to assess the measured parameters to determine if a firstor second indication from the implantable medical device has beenreceived.
 28. The external charger of claim 27, wherein if the firstindication is received, the algorithm is configured to energize the coilto generate a magnetic field to charge the battery in the implant untilthe battery is fully charged.
 29. The external charger of 27, wherein ifthe second indication is received, the algorithm is configured toenergize the coil to generate a magnetic field to charge the battery inthe implant for a set time period.
 30. The external charger of claim 18,wherein the control circuitry comprises a microcontroller.
 31. Theexternal charger of claim 20, wherein the algorithm is programmed intothe microcontroller.
 32. The external charger of claim 18, wherein thedriver circuitry comprises an amplifier.
 33. The external charger ofclaim 18, wherein the detection circuitry comprises an Load Shift Keyingdemodulator and a coupling detector.
 34. The external charger of claim18, wherein the external charger is hand-holdable.
 35. The externalcharger of claim 18, wherein the driver circuitry is configured toenergize the coil to generate a magnetic field at a single frequency.36. The external charger of claim 18, further comprising an alignmentdetector to indicate external charger alignment to a user while thealgorithm energizes the coil to generate a magnetic field to charge thebattery in the implant.